Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

• Subjects must have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• NOTE: Subjects with carcinosarcoma histology and/or mixed epithelial histology are not eligible.
• Subjects must have recurrent, platinum resistant or refractory disease, defined as progression = 18 years
• Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Hemoglobin >= 9.0 g/dL (within = = 3.0 x 10^9/L (within = = 1.5 x 10^9/L (within = = 75 x 10^9/L (within = 1.5 x ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) = = 3.0 g/dL
• Serum creatinine = = 6 months prior to registration, and subjects must be receiving effective anti-retroviral HIV therapy, if indicated
• NOTE: HIV testing is not required for subjects without a known history of HIV, unless mandated by a local health authority
• For subjects with a known history of hepatitis B virus (HBV) infection or hepatitis C virus (HCV) infection, the HBV/HCV viral load must be undetectable, and subjects must be receiving effective suppressive HBV/HCV therapy, if indicated.
• NOTE: HBV and HCV testing is not required for subjects without a known history of HBV or HCV, unless mandated by a local health authority
• Subjects with previously treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for >= 28 days prior to registration, and any neurologic symptoms have returned to baseline
• Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial are eligible
• Subjects with a known history severe cardiac disease, current symptoms of cardiac disease (e.g., unstable angina pectoris or cardiac arrhythmia), or a history of treatment with cardiotoxic agents should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, these subjects must be class 2B or better
• For subjects with hypertension, hypertension must be well controlled on medication.
• NOTE: Uncontrolled hypertension is defined as a consistent blood pressure (bp) of >= 160 mmHg systolic or >= 100 mmHg diastolic, on initial and repeat checks
• Females of reproductive potential must agree to undergo a urine or serum pregnancy test, and the results must be negative in order to initiate treatment.
• NOTE: A female of reproductive potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy
• Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
• Females of reproductive potential must agree to use adequate contraception (abstinence or two methods of birth control, such as a barrier method in combination with hormonal contraception) while receiving trial therapy and for 6 months following completion of trial therapy. Should a woman become pregnant or suspect she is pregnant while is participating in this study, she should inform her treating physician immediately.
• NOTE: A female of reproductive potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy
• Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
• Subjects must agree to not nurse/breastfeed while receiving trial therapy and for 6 mo